HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL— 510(k) K913792

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K913792 for HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL, Substantially Equivalent on 1991-09-25. Applicant: Hichem Diagnostics.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1991-08-23
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.